Mild Cognitive Impairment(VR-MCI)NCT07638748
Feasibility, Usability, and Acceptability of Virtual Reality-Based Cognitive and Physical Rehabilitation in Individuals With Mild Cognitive Impairment
A study testing Virtual Reality (VR) sessions in people with Mild Cognitive Impairment and Subjective Cognitive Decline (SCD), run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate feasibility, usability, and acceptability of virtual reality (VR)-based cognitive and physical rehabilitation, evaluate adherence, tolerability, and fidelity to the VR intervention and explore preliminary effectiveness of VR-based rehabilitation on cognitive, physical, and… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment, Subjective Cognitive Decline (SCD)
- What is being tested?
- Virtual Reality (VR) sessions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2026to 13 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of MCI (MoCA 18-26) or self-reported subjective cognitive decline (SCD)
- Capacity to provide informed consent
- Able to provide own transportation to sessions
- Speaks and understands English
- Ambulatory
Who cannot join
- Uncontrolled seizures or epilepsy
- Severe psychiatric illness or active suicidality
- Inability to follow instructions or tolerate VR (severe motion sickness)
- Cognitive impairment as a result of a known cause (e.g., dementia, stroke, Traumatic Brain Injury (TBI), medications, etc.)
- Any condition that the research team determines would interfere with safe participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Seema Aggarwal, PhD, APRN, AGNP-C, (713) 500-9946, Seema.S.Aggarwal@uth.tmc.edu
Tela Todd, (713) 500-7039, Tela.Todd@uth.tmc.edu
About this study
Official title: Feasibility, Usability, and Acceptability of Virtual Reality-Based Cognitive and Physical Rehabilitation in Individuals With Mild Cognitive Impairment (VR-MCI)
The purpose of this study is to demonstrate feasibility, usability, and acceptability of virtual reality (VR)-based cognitive and physical rehabilitation, evaluate adherence, tolerability, and fidelity to the VR intervention and explore preliminary effectiveness of VR-based rehabilitation on cognitive, physical, and functional outcomes.
- Being tested
- Virtual Reality (VR) sessions
- Keywords
- Virtual Reality, Cognitive Rehabilitation, Physical Rehabilitation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) sessionsDevice
Participants will complete 3 supervised virtual reality (VR) sessions per week for 6 weeks for a total of 18 sessions using either the Real System VR headset or the Oculus Quest 2 VR headset. Each session will last approximately 60 minutes, with time allocated for setup and brief symptom checks.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) sessions | Experimental | Not described Receives: Device: Virtual Reality (VR) sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by the recruitment rate
Measured: from baseline to end of intervention (6 weeks)
Feasibility as assessed by the retention rate
Measured: from baseline to end of intervention (6 weeks)
Feasibility as assessed by the session completion rate
Measured: from baseline to end of intervention (6 weeks)
Usability as assessed by the System Usability Scale (SUS)
The System Usability Scale (SUS) is a validated 10-item questionnaire used to assess participants' perceived usability of the intervention. each rated on a 5-point Likert scale from 1 = Strongly Disagree, 2 = Disagree 3 = Neutral ,4 = Agree, 5 = Strongly Agree. Scores range from 0 to 100, with higher scores indicating greater usability.
Measured: Post-intervention only (Final visit at 6 weeks)
Acceptability / Presence as assessed by the Presence Questionnaire (PQ)
This is a 29 item questionnaire, each is scored on a seven-point Likert-type scale with a score range form 29-203. Higher scores indicate a greater sense of presence or immersion in the virtual environment.
Measured: Post-intervention only (Final visit at 6 weeks)
Tolerability / Side Effects as assessed by the Simulator Sickness Questionnaire (SSQ)
This is a 16 item questionnaire and each is scored form 0(none) to 3(severe). Scores are combined using weighted subscales to generate a total score, with higher scores indicating greater simulator sickness
Measured: Before + immediately After each VR session
Adherence / Engagement as assessed by the session attendance as entered in VR system logs
Measured: Post-intervention only (Final visit at 6 weeks)
Adherence / Engagement as assessed by the time from start to end of VR session as entered in VR system logs
Measured: Post-intervention only (Final visit at 6 weeks)
Adherence / Engagement as assessed by the number of repetitions of the activity as indicated by device metrics
Measured: Post-intervention only (Final visit at 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start18 Jun 2026
- Primary completion13 Nov 2026 (estimated)
- Study completion13 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- DPRIT Seed Grant
- Responsible party
- Principal investigator, Seema S Aggarwal, The University of Texas Health Science Center, Houston
- Investigators
- Seema Aggarwal, PhD, APRN, AGNP-C, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638748
- Sponsor's protocol ID
- HSC-MS-26-0038
- Acronym
- (VR-MCI)
- Status last verified
- Aug 2026
- First submitted
- 2 Jun 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Usability, and Acceptability of Virtual Reality-Based Cognitive and Physical Rehabilitation in Individuals With Mild Cognitive Impairment (VR-MCI)
- ClinicalTrials.gov ID
- NCT07638748
- Acronym / sponsor ID
- (VR-MCI) / HSC-MS-26-0038
- Keywords
- Virtual Reality, Cognitive Rehabilitation, Physical Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- DPRIT Seed Grant
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 13 Nov 2026 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate feasibility, usability, and acceptability of virtual reality (VR)-based cognitive and physical rehabilitation, evaluate adherence, tolerability, and fidelity to the VR intervention and explore preliminary effectiveness of VR-based rehabilitation on cognitive, physical, and functional outcomes.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) sessions | Experimental | Device: Virtual Reality (VR) sessions |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of MCI (MoCA 18-26) or self-reported subjective cognitive decline (SCD)
- Capacity to provide informed consent
- Able to provide own transportation to sessions
- Speaks and understands English
- Ambulatory
Key exclusion criteria (5 listed)
- Uncontrolled seizures or epilepsy
- Severe psychiatric illness or active suicidality
- Inability to follow instructions or tolerate VR (severe motion sickness)
- Cognitive impairment as a result of a known cause (e.g., dementia, stroke, Traumatic Brain Injury (TBI), medications, etc.)
- Any condition that the research team determines would interfere with safe participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality (VR) sessionsParticipants will complete 3 supervised virtual reality (VR) sessions per week for 6 weeks for a total of 18 sessions using either the Real System VR headset or the Oculus Quest 2 VR headset. Each session will last approximately 60 minutes, with time allocated for setup and brief symptom checks. | Device | Virtual Reality (VR) sessions |
Primary outcome
Feasibility as assessed by the recruitment rate
Time frame: from baseline to end of intervention (6 weeks)
Feasibility as assessed by the retention rate
Time frame: from baseline to end of intervention (6 weeks)
Feasibility as assessed by the session completion rate
Time frame: from baseline to end of intervention (6 weeks)
Usability as assessed by the System Usability Scale (SUS)
Time frame: Post-intervention only (Final visit at 6 weeks)
The System Usability Scale (SUS) is a validated 10-item questionnaire used to assess participants' perceived usability of the intervention. each rated on a 5-point Likert scale from 1 = Strongly Disagree, 2 = Disagree 3 = Neutral ,4 = Agree, 5 = Strongly Agree. Scores range from 0 to 100, with higher scores indicating greater usability.
Acceptability / Presence as assessed by the Presence Questionnaire (PQ)
Time frame: Post-intervention only (Final visit at 6 weeks)
This is a 29 item questionnaire, each is scored on a seven-point Likert-type scale with a score range form 29-203. Higher scores indicate a greater sense of presence or immersion in the virtual environment.
Tolerability / Side Effects as assessed by the Simulator Sickness Questionnaire (SSQ)
Time frame: Before + immediately After each VR session
This is a 16 item questionnaire and each is scored form 0(none) to 3(severe). Scores are combined using weighted subscales to generate a total score, with higher scores indicating greater simulator sickness
Adherence / Engagement as assessed by the session attendance as entered in VR system logs
Time frame: Post-intervention only (Final visit at 6 weeks)
Adherence / Engagement as assessed by the time from start to end of VR session as entered in VR system logs
Time frame: Post-intervention only (Final visit at 6 weeks)
Adherence / Engagement as assessed by the number of repetitions of the activity as indicated by device metrics
Time frame: Post-intervention only (Final visit at 6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seema Aggarwal, PhD, APRN, AGNP-C principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) sessions in people with Mild Cognitive Impairment and Subjective Cognitive Decline (SCD), run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seema S Aggarwal, PhD, APRN, AGNP-C ((713) 500-9946, Seema.S.Aggarwal@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by the recruitment rate (time frame: from baseline to end of intervention (6 weeks)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.